Severe acute malnutrition Nutritional, Metabolic, Endocrine Malnutrition
Conditions
Interventions
Randomisation will be in permuted blocks. Cards with treatment allocation (standard or altered standard with chickpea flour) will be prepared in Kilifi and sent to Mbale. They will be kept in numbered
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Marasmus defined by mid-upper arm circumference < 11.5cm 2. Kwashiorkor defined as symmetrical pitting oedema involving at least the feet irrespective of WHZ score or MUAC 3. Guardian/parent willing and able to provide consent
Exclusion criteria
Exclusion criteria: Children with severe acute malnutrition with very high risk of death due to comorbidity, e.g. malignant disease or terminal illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mid-upper arm circumference in centimeters and millimeters measured using measuring tape supplied by UNICEF designed for this purpose on admission (at trial recruitment), day 7, day 28 and day 90 2. Survival recorded by incidence of death up to day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 16/09/2021: 1. Weight measured daily from admission to discharge, then at day 28 and day 90, by clinical weighing scales. Daily weight (in grams and kilograms) change is calculated from this to assess response to the intervention, and moderate weight gain defined as being >5g/kg/day 2. Development of diarrhoea assessed by daily recording of stool passed during inpatient stay, and diagnosed if >3 watery stools are passed in any one day. Inpatient stay is variable, but likely to be minimum of 14 days. Children/parents are asked about number and consistency of stool passed at day 28 and day 90 reviews 3. Time to resolution of diarrhoea assessed in patients who presented with diarrhoea on admission (>3 watery stools in one day) during inpatient stay. Daily inpatient monitoring of stool passed is undertaken, and resolution defined as cessation of passing >3 watery stools in one day. Children/parents are asked about number and consistency of stool passed at day 28 and day 90 reviews 4. Presence of oedema recorded on admission assessed visually and severity recorded as affecting pretibial only (mild), involving hands/feet (moderate), or generalised (severe). Oedema monitored daily during inpatient admission, and at time to resolution noted. Presence of oedema assessed at day 28 and day 90 reviews also 5. Faecal calprotectin (by ELISA) used to assess inflammation in the gut, analysed on collected faecal samples at admission, day 7, day 28 and day 90 6. Safety assessed by reports of serious adverse events to include any untoward medical occurrence or effect that is 1) fatal, 2) life threatening, 3) permanently or temporarily disabling or incapacitating, 4) causes prolongation of hospital stay, or 5) any other event deemed to have a real risk of resulting in one of the previous outcomes. Allergic reactions will be considered SAEs. SAEs reported immediately to the on-site PI, and captured in a dedicated form at the time of event or the | — |
Countries
Uganda
Contacts
Public ContactKevin Walsh
Outcome results
None listed